An Investigator Initiated Study to Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion

Healthy Clinical Trial

Official title:

Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963247
• Other study ID #: ELM-22
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: April 8, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: ElMindA Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.

The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.

The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system while the subject is performing a cognitive task in front of a computer. The EEG data is then analyzed using the advanced BNA™ technology. Finally, a report of the BNA™ test is generated.

Description:

A single center study evaluating the effectiveness of BNA technology as an objective tool for sport related concussion management in youth athletes' populations.

The study will include 150 athletes from Minnesota Youth Hockey Programs. Subjects enrolled in this study will undergo a screening and baseline pre season visit and follow up visit/s.

1. Follow-up testing for concussed athletes - Concussed athletes will complete a series of post concussion follow up visits. Each will consist of BNA™ test, ImPACT™ test, and exam by neurologist or neurology nurse practitioner. The first visit will be within 72 hours of injury and re-evaluations will occur weekly until BNA has normalized AND subject is asymptomatic. Subject may return to play at that point and subject will have a final additional BNA™ test one week after the athlete returns to full activity. If participant is still symptomatic and/or BNA is still abnormal at 6 weeks reevaluations go to every 2 weeks for up to three months or clearing of symptoms AND normal BNA™. If not back to baseline at three months, monthly reevaluations until study completion.

2. Follow up visit for non-concussed athletes - non-concussed athletes will complete a follow up visit upon completion of the sport season.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Male athletes

• aged 11-15

• enrolled in selected Minnesota Youth Hockey Programs

Exclusion Criteria:

• Self-reported history of central nervous system injury or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale < 13), epilepsy, seizures, brain surgery, or any positive neuroimaging results)

• Active head lice infection, open scalp wound

• Deafness, and/or blindness

• A concussion within prior six months

• Residual symptoms or deficits related to a previous concussion

• Long and thick hair that prevents the proper administration of an EEG cap.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• Minor Traumatic Brain Injury (TBI)

Locations

Country	Name	City	State
United States	Noran Neurological Clinic	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
ElMindA Ltd	Noran Neurological Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in BNA™ measures during the sport season	Consistency or changes in BNA™ measures during and after the sport season in both concussed and non concussed athletes compared to pre season BNA™ baseline measures.	1 year	No
Primary	Correlation of the BNA measures during the sport season in concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.	Correlation of the BNA measures during the sport season in concussed athletes to the clinical diagnosis, symptom scores and the ImPACT test results.	1 year	No